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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: FBK FDA class 2

    Endoscopic Injection Needle, Gastroenterology-Urology

    Gastroenterology, Urology

    View full classification →

    The Endoscopic Injection Needle for Gastroenterology-Urology (product code FBK) is a needle device inserted through an endoscope to inject solutions, gas, or implantable materials into gastrointestinal or genitourinary tissue. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    EzVu Visual Vasopressor injector (EV-19)
    Endoscopic Injection Needles
    injeTAK Adjustable Tip Needle (DIS199; DIS201)
    Disposable Injection Needles
    Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)
    Disposable Endoscope Injection Needles
    Disposable Injection Needle AF series
    Sclerotherapy & Endoscopic Needles
    CORE-INJECTOR
    LiNA OperaScope Needle
    Disposable Endoscope Injection Needle
    Injection Needle
    Endoscopic Injection Needle
    Sclerotherapy Needle
    Single Use Injection Needle
    Single Use Injector
    Disposable Sclerotherapy Needle
    Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)
    Clear-Jet Injection Catheter
    Repris Bladder Injection System
    Endoscopic Injection Needle
    Williams Cystoscopic Injection Needle
    Interject Injection Therapy Needle Catheter
    Single Use Injector NM600/610
    EndoChoice Select Injection Needle
    iSnare system-Lariat
    Injection Needle
    DISPOSABLE INJECTION NEEDLE
    BIOMARC COAXIAL NEEDLE
    INJECTION NEEDLE
    UROPLASTY RIGID ENDOSCPIC NEEDLES
    INJEKT CYSTO FLEXIBLE INJECTION NEEDLE
    COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
    ERBELIFT HAND PUMP AND FLEXIBLE PROBE
    LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP
    UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518
    BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
    INJEKT FILIFORM INJECTION NEEDLE
    INJECTRA INJECTION NEEDLE
    N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110
    UROPLASTY RIGID ENDOSCOPIC NEEDLE
    TEGRESS IMPLANT NEEDLE
    ENTERYX INJECTION CATHETER
    CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE
    VARICES NEEDLE
    CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE
    COOK INJECTION NEEDLE
    ENTERYX INJECTOR
    VARICES INJECTION NEEDLE
    OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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